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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Version / remarks:
July 30, 1996
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 400047.32
- Expiration date of the lot/batch: December 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature (approx. 20 °C); away from direct sunlight
- Stability under test conditions: Stable in polyethylene glycol (PEG 400) for at least 24 hours.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf/ Switzerland
- Age at study initiation: Males - 8 weeks; Females - 10 weeks
- Weight at study initiation: Males - 200-214 g; Females - 183-189 g
- Fasting period before study: overnight
- Housing: Groups of five in Makrolon type-4 cages with standard softwood bedding
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
The animals received a single dose of the test article at 2000 mg/kg body weight basis by oral gavage following fasting for approximately 16.5 h, but with free access to water. Food was provided again approximately 3 h after dosing.

Dose / kg body weight: 2000 mg

Application volume / kg body weight: 10 ml

Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.
Doses:
2000 mg/ kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs - Daily, Body weight - 1, 8 and 15 day
- Necropsy of survivors performed: yes
Statistics:
The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range of physiological variability known for rats of this strain and age
Gross pathology:
No macroscopic organ findings were observed at necropsy.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean lethal dose (LD50) of FAT 21016/C after single oral administration in Wistar rats of both sexes is greater than 2000 mg/kg bw.
Executive summary:

Following OECD Guidelines for the Testing of Chemicals, Number 401 "Acute Oral Toxicity", Wistar rats were exposed to test substance FAT 21016/C to determine median lethal concentration (LD50). A group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 21016/C at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (PEG 400) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths nor clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic organ findings were observed at necropsy. In conclusion, the mean lethal dose (LD50) of FAT 21016/C after single oral administration in Wistar rats of both sexes is greater than 2000 mg/kg bw.